Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial.

ABSTRACT:

Objective

To assess the efficacy and safety of pyrotinib (an irreversible pan-HER (human epidermal growth factor receptor) inhibitor), trastuzumab, and docetaxel compared with placebo, trastuzumab, and docetaxel for untreated HER2 positive metastatic breast cancer.

Design

Randomised, double blind, placebo controlled, multicentre, phase 3 trial.

Setting

40 centres in China between 6 May 2019 and 17 January 2022.

Participants

590 female patients (median age 52 (interquartile range 46-58) years) with untreated HER2 positive metastatic breast cancer.

Interventions

Eligible patients were randomised 1:1 to receive either oral pyrotinib (400 mg once daily) or placebo, both combined with intravenous trastuzumab (8 mg/kg in cycle 1 and 6 mg/kg in subsequent cycle

SUBMITTER: Ma F 

PROVIDER: S-EPMC10616786 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature